Stryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues
Stryker Orthopaedics is recalling ShapeMatch Cutting Guides used in knee surgeries due to potential issues with internal planning and production processes.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences.
Plain-English summary
Stryker Orthopaedics is recalling ShapeMatch Cutting Guides, which are patient-specific surgical instruments used to assist in the positioning of total knee arthroplasty components and to guide bone marking during surgery. The recall involves 7,868 units of Catalog No. TR7100-L and TR7100-R, distributed nationwide in the United States.
The recall was initiated because Stryker Orthopaedics became aware of potential issues associated with internal processes for planning cases and producing the cutting guides using MRI imaging. The source text does not specify the exact nature of the process failures or report any specific injuries or illnesses.
Healthcare providers and patients who have used or are scheduled to use these specific cutting guides should contact Stryker Orthopaedics for further instructions. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 7,868
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog No: TR7100-L and TR7100-R Lot Code: All
Distribution
Distributed nationwide across the United States.
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